BACKGROUND AND PURPOSE:

• Candesartan is an angiotensin receptor blocker currently used for hypertension and heart failure and is available as a generic
• Øie et al. (The Lancet, 2025) evaluated the safety, tolerability, and efficacy of candesartan for the preventive treatment of episodic migraine

METHODS:

• Randomized, triple-blind, placebo-controlled, parallel-group trial
  • Norway and Estonia
• Participants
  • Adults 18 to 64 years
  • Experiencing 2 to 8 migraine attacks (with or without aura) per month
• Interventions
  • Oral candesartan 16 mg daily for 12 weeks
  • Placebo
• Study design
  • Acute migraine medication was permitted during the trial
    • Use of additional preventative treatments was prohibited
  • Analysis was by intention to treat
  • Safety analysis included all participants who received ≥1 dose of the trial drug
• Primary outcome
  • Change in mean number of migraine days per 4 weeks from baseline, to weeks 9 to 12

RESULTS:

• Candesartan 16 mg: 156 participants | Candesartan 8 mg: 150 participants | Placebo: 151 participants
  • Mean age: 38.7 (SD, 10.0) | Female: 86%
  • Mean number of migraine days at baseline: 5.7 (SD, 2.5)
• At weeks 9 to 12, there was a significant reduction in number of migraine days in both the candesartan 16 mg group and the placebo group, though the reduction was significantly greater in the candesartan 16 mg group
  • Candesartan 16 mg: 2.04 days (95% CI, 1.65 to 2.41) | P<0.0001
  • Placebo: 0.82 days (95% CI, 0.38 to 1.23) | P=0.0003
  • Difference: –1.22 (59% CI, –1.75 to –0.70) | P<0.001
• The most common adverse event with candesartan 16 mg was dizziness
  • Candesartan 16 mg: 30% | Placebo: 13%
• Serious adverse events
  • Candesartan 16 mg group: 3% | Placebo group: 1%
• Adverse events leading to discontinuation
  • Candesartan 16 mg: 3% | Placebo: 3%

CONCLUSION:

• In this multicenter study, daily candesartan 16 mg was an effective preventative treatment for those with episodic migraine
• The authors state

These findings support its role as a clinically meaningful and evidence-based option for migraine prevention

However, further clinical trials and real-world data from registry studies are necessary to assess its long-term efficacy

Learn More – Primary Sources:

Candesartan versus placebo for migraine prevention in patients with episodic migraine: a randomised, triple-blind, placebo-controlled, phase 2 trial